Safety Risk Lead Associate

Job Post Index 23C1DA-Sy##
Location Virtual, US
Description: Job Description
  • Act as a Point of Contact for Safety in the Asset Teams, ensuring a unified communication on safety matters and representing WWS position(s) on safety
  • Provides disease area specific pharmacovigilance expertise, and applies this to various business unit products assigned to the SRL operating from a SSRM DA-Cluster.
  • Ensures consistency of Safety Risk Messaging for a particular product or class of products, across multiple indications/BUs within the many safety reports and communications for that product.
  • Providing suitable summaries of product risks to summary document authors where appropriate, for example providing medical content/B-R statements and overall risk messaging of the safety profile to WMS/PSSR Authors.
  • Performs ad hoc special scholarly Safety Surveillance and Risk Management activities, rapidly, to meet specific needs in the BUs, such as RRT deliverables/emerging safety issue white papers/product Due Diligence Assessments.
  • Identifies opportunities for Consistency and Standards for Safety Surveillance and Risk Management approaches and processes within a DA-Cluster and across BUs, and supporting the piloting and implementation of such.
  • Innovates, champions and implements novel approaches to Safety Surveillance and Risk.
  • Management across BUs: engages in Continuous Improvement initiatives, Safety Sciences Research and Communications activities, including methodological improvements.
  • Engages in inspection readiness and support.
  • Provision of data to project managers for metrics and activity tracking.
  • Frequently independently performs evaluation of all sources of safety data, identifies and independently analyzes safety signals, and presents evaluation of safety signals and benefit risk assessments to the appropriate forums.
  • Contributes SSRM perspective and subject matter expertise to all relevant areas of risk management plans, expert reviews, Health Authority Queries and other documents as required.
  • Prepares basic action plans independently to address risk and benefit-risk issues.
  • Handles more advanced/complex plans with direction/coaching.
  • Conducts and Represents SSRM on due diligence activities.
  • Provides guidance and/or oversight to SSRM colleagues on safety issues. 
  • Provides formal and informal education to other SSRM colleagues on key safety and pharmacovigilance topics.
  • Represent WWS on safety and benefit-risk issues to external groups including regulatory authorities and business partners.
  • Contributes to review and development of intradepartmental policies and procedures as appropriate.
  • Initiates, conducts and chairs Risk Management Committee, P-BRC (co-chair) and CWGs with minimal oversight.
  • Prepares and contributes to written safety assessments and benefit-risk evaluations.
  • Reviews safety assessments/evaluations/contributions prepared by senior manager SRLs and other safety colleagues.
  • Completes all assigned activities with minimal guidance.
  • Makes decisions based on clinical experience.
  • Utilizes knowledge of integrated body systems’ pathophysiology to evaluate the impact of product issues.
  • Assesses the suitability of biopharmaceutical products on typical physician practice within various health systems, hospital and non-hospital patient care facilities.
  • Ensures products fulfil quality medical care.
Skills: Qualifications
  • MSc.
  • Preferred Health professional degree
  • Familiarity with safety surveillance software
  • Technical Skills, (plus knowledge, experience and ability in):Safety data review, Safety data assessment, Clinical Safety signal identification, risk
  • Thorough understanding of Safety Risk Management internal and external environment, including applicable regulations and guidance's
  • Clinical development and post-marketing experience to have an understanding of safety context across the drug lifecycle
  • Demonstrated leadership in day-to-day activities and collaborative skills
  • Demonstrated self-awareness and interpersonal skills

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